MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 34MM

Model Number	1194.2034
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.It was reported that a screw backed out past the locking mechanism at the bottom level of a 2 level resonate plate.The original surgery date was (b)(6) 2023.The back-out was discovered on 6-10 month follow up images.The post-op image provided shows several millimeters of the screw being proud of the plate at the bottom level of the 2-level plate.It also appears the allograft spacer is broken at the bottom level.In the immediate post-op images, there is a dark spot next to the bottom level of the plate which may be a fragment of the slider blocking mechanism.It is unclear whether some damage occurred to the plate or sliders inter-operatively or what the cause of the issue could have been.It was reported there was no pain or adverse effect to the patient.The screw was removed during a revision surgery (b)(6) 2024.The plate was left in the patient.The screw was discarded by the hospital.No determinations can be made for the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was needed to replace a screw that backed out of a resonate plate post-operatively.

• Brand Name: RESONATE
• Common Device Name: RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 34MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 19446654
• Report Number: 3004142400-2024-00104
• Device Sequence Number: 12948552
• Product Code: KWQ
• UDI-Device Identifier: 00193982154851
• UDI-Public: 00193982154851
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1194.2034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown